Respiratory Outcome at Adolescence of Very Low Birthweight Infants

Assistance Publique - Hôpitaux de Paris355 enrolled

Overview

EPIPAGEADO is an observational study. Respiratory symptoms and lung function will be evaluated in very low birth weight and term infants, born in 1997 and included in the French EPIPAGE cohort.

EPIPAGEADO is a multicenter observational study:- to evaluate respiratory symptoms and lung function at adolescence in very low birthweight (VLBW) children, to identify perinatal risk factors for persistent symptoms or impaired lung function tests at adolescence, to assess the exercise tolerance in VLBW children and to search for genetic susceptibility markers associated to impaired lung function. The main criteria for analysis will be the forced expiratory volume in one seconde (FEV1) The study duration will be 36 months the number of centers will be 4 centers in France (Paris-Necker, Nantes, Lille, Rouen) The number of patients to be included will be 400, including 260 VLBW children without BPD, 40 VLBW children with BPD, 100 control children with birth at term.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

355

Conditions

Premature Baby 26 to 32 Weeks Bronchopulmonary Dysplasia

Interventions

Prevention and follow-up of the patients pulmonary parametersOTHER

Respiratory symptoms and lung function will be evaluated in very low birth weight and term infants, born in 1997 and included in the French EPIPAGE cohort.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 15 Years

Medical Language ↔ Plain English

Inclusion criteria : * Children born in 1997, and included at birth in the French EPIPAGE cohort * Absence of severe neurologic impairment, with impossibility of reliable lung function tests * Acceptance of the child and his/her parents Exclusion criteria : * Severe neurologic impairment, with impossibility of reliable lung function tests * Absence of child's or parents' acceptance

Locations (1)

Hopital Necker

Paris, France

Outcomes

Primary Outcomes

Forced expiratory volume

Forced expiratory volume in one seconde (FEV1) at 14-15 years

Time frame: Day 0 (at 14 - 15 years old)

Secondary Outcomes

Pulmonary parameters

Pulmonary parameters will be assess by the measure of Vital capacity, total lung capacity, functional residual capacity, forced expiratory flow 25-75%, diffusing capacity for carbon monoxide, diffusing capacity for nitric monoxide, exhaled nitric monoxide, maximal oxygen consumption at exercise.

Time frame: Day 0 (at 14 - 15 years old)

Standardized questionnaire for respiratory symptoms

Time frame: Day 0 (at 14-15 years old)

Candidate-gene analysis, with SNPs known to be associated to bronchopulmonary dysplasia (BPD)

Time frame: Day 0 (at 14-15 years old)

Data from ClinicalTrials.gov

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